Expired Study
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Nashville, Tennessee 37232


Purpose:

This placebo-controlled study investigates acetyl-L-carnitine in the treatment of septic shock requiring vasopressors.


Study summary:

This is a cross-over study which infuses ALC for 12 out of 18 hours (and placebo the other 6). Patients must have vasopressor-dependent septic shock and be free from renal failure, hepatic failure, and seizures to be eligible.


Criteria:

Inclusion Criteria: - documented or presumed infection - shock requiring vasopressors Exclusion Criteria: - dialysis - hepatic failure - seizures


Study is Available At:


Original ID:

050730


NCT ID:

NCT00592488


Secondary ID:


Study Acronym:

ALC


Brief Title:

Acetyl-L-Carnitine in the Treatment of Septic Shock


Official Title:

Prospective, Randomized, Placebo-controlled, Double-Blinded, Phase II Pilot Study of Acetyl-L-carnitine in the Treatment of Patients With Septic Shock


Overall Status:

Completed


Study Phase:

Phase 1/Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Vanderbilt University Medical Center


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

13


Enrollment Type:

Actual


Overall Contact Information

Official Name:Todd W. Rice, MD, MSc
Principal Investigator
Vanderbilt University

Study Dates

Start Date:August 2006
Completion Date:September 2009
Completion Type:Actual
Primary Completion Date:August 2009
Primary Completion Type:Actual
Verification Date:November 2017
Last Changed Date:November 7, 2017
First Received Date:January 2, 2008
First Results Date:March 17, 2011

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Serum Lactate
Time Frame:12-36 hours
Safety Issues:False
Description:Latest serum lactate between 12 and 36 hours
Outcome Type:Secondary Outcome
Measure:Vasopressor Dose
Time Frame:6-24 hours
Safety Issues:False
Description:Change in vasopressor dose between 6 and 24 hours.
Outcome Type:Primary Outcome
Measure:Mean Arterial Blood Pressure
Time Frame:18 hours
Safety Issues:False
Description:Mean Arterial blood pressure measured non-invasively at 18 hours

Study Interventions

Intervention Type:Drug
Name:Acetyl-L-Carnitine
Description:Acetyl-L-Carnitine - 4 g IV over 30 minutes, then 8 g iv over the next 12 hours
Arm Name:A
Other Name:ALC

Study Arms

Study Arm Type:Other
Arm Name:A
Description:Placebo for first 6 hours then Acetyl-L-Carnitine (ALC) for 12 hours
Study Arm Type:Other
Arm Name:B
Description:Acetyl-L-Carnitine (ALC) for first 12 hours then placebo for next 6 hours

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Vanderbilt University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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